Patient-Specific Computational Walking Models in Improving Surgical and Rehabilitation Treatment in Patients With Pelvic Sarcomas
Study Details
Study Description
Brief Summary
This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of patients with pelvic sarcomas. Every pelvis and pelvic sarcoma are different, and the orthopedic oncologist faces significant challenges when removing a tumor from the complex anatomy of the pelvis. These challenges make it difficult to achieve excellent oncological and functional outcomes together. Computational walking models may be used to predict the best combination of surgical methods and how to implement them to maximize each patient's post-surgery walking function.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
PRIMARY OBJECTIVES:
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To develop patient-specific computational walking models to predict the optimal combination of pelvic sarcoma surgical and rehabilitation decisions that will maximize each patient's post-surgery walking function.
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To collect experimental movement and imaging data prospectively and retrospectively from individuals who have already received, or are going to receive, a type I or type II hemipelvectomy.
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To use the data to develop computational modeling and simulation methodologies that can predict an individual patient's post-surgery walking function given pre-surgery movement and imaging data and the surgical decisions made by the surgeon.
OUTLINE:
Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Supportive care (walking function test, X-ray) Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy. |
Other: Functional Assessment
Undergo walking function assessment with optical motion capture
Procedure: X-Ray Imaging
Undergo bi-plane dynamic X-ray imaging
Other Names:
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Outcome Measures
Primary Outcome Measures
- To establish the patient-specific computational models to inform surgical decisions and design custom implants that maximize post-surgery function. [through study completion, an average of 1 year]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients who have received or are scheduled to receive a type II or any combination of type II (e.g., type I + II, II + III, or I + II + III) hemipelvectomy surgery without reconstruction or with allograft reconstruction at University of Texas (UT) MD Anderson Cancer Center.
Exclusion Criteria:
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Patients whose leg has been or will be amputated by hemipelvectomy surgery.
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Previous surgery or significant injury to either hip.
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Relevant surgery, procedure, injury, or condition in the last two years which may affect hip pain or general movement patterns on either side.
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Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health.
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Pregnant women or women nursing an infant.
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Persons with body mass index (BMI) > 30 and/or waist size > 100 cm (39 in) (these individuals would likely require higher radiation doses than are specified for this study).
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Persons with a history of significant radiation exposure (greater than 25 mSv), whether occupational or medical in nature. Anyone with a history of medical radiation therapy (for cancer or other conditions) is excluded from the study.
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Persons with a pacemaker, hearing aid, aneurysm clips or artificial heart valves, and other forms of loose metal implants will be excluded from the study as assessed by a pre-magnetic resonance imaging (MRI) questionnaire administered by the MRI technician at the time of the scan.
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Radiological exclusion criteria (assessed after magnetic resonance [MR] scan is conducted on the first visit, prior to dynamic stereo X-ray [DSX]/computed tomography [CT] radiation exposure): evidence on preliminary MRI of avascular necrosis (AVN), fracture, slipped capital femoral epiphysis (SCFE), collapsed joint space or advanced osteoarthritis, hip dysplasia, masses, lesions, or other anomalies not consistent with a femoro-acetabular impingement (FAI) diagnosis.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | M D Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Valerae O Lewis, M.D. Anderson Cancer Center
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 2018-0216
- NCI-2019-00862
- 2018-0216